Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

Incisional Hernia After Diverting Stoma Closure Clinical Trial

— MEMBO  

Official title:

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576184
• Other study ID #: P140312
• Secondary ID: 2015-A00410-49
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: November 15, 2020

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Description:

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery

• Signed consent

• Affiliation to the French social security system

Exclusion Criteria:

• Emergency surgery

• History of laparotomy before ileostoma closure.

• Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy

• Lactating or pregnant woman

• Allergy to porcine product or collagen-based product. Allergy to polypropylene.

• Participation to another protocol focusing on ileostoma closure

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia After Diverting Stoma Closure
• Rectal Neoplasms

Intervention

Device:
• Biologic Mesh
Biologic mesh placed in retromuscular position during ileostoma closure
• Synthetic Mesh
synthetic mesh placed in retromuscular position during ileostoma closure

Locations

Country	Name	City	State
France	Service de Chirurgie Colorectale - Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiological incisional hernia rate	Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up.; Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient	up to 36 months
Secondary	Postoperative morbidity	Postoperative morbidity	30 days
Secondary	Postoperative pain	Score Brief Pain Inventory	36 months
Secondary	Postoperative rehospitalization	Case report form data	36 months
Secondary	Postoperative reintervention	Case report form data	36 months
Secondary	Quality of life (The Short Form (36) Health Survey score)	The Short Form (36) Health Survey	12 months
Secondary	Clinical incisional hernia rate	Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient	36 months